Knee Injuries
Conditions
Keywords
anterior cruciate ligament (ACL), Multiple Knee Ligament Reconstruction
Brief summary
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial controlled weightbearing for the first six weeks after surgery.
Detailed description
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery: 1. non-weightbearing 2. partial weightbearing An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions. Specific Aims 1. Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation. 2. Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation. 3. Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups. The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.
Interventions
OTHERPhysical Therapy
Patient is randomized to the weightbearing group the day after surgery.
Sponsors
Twin Cities Orthopedics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* ≥ 14 years old, \<60 * Reconstruction of PCL alone * Reconstruction of MCL alone * Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL)) * Reconstruction of multiligament injuries (ACL+MCL) * Males or females * Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
Exclusion criteria
* \< 14 years old * \>60 years old * Pregnant * Revision PCL reconstructions * Previous or concurrent vascular injury (vascular bypass procedure) * Associated fractures requiring concurrent surgery * Concurrent meniscal root or radial repair surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gapping (mm) measured on Standard of Care Varus stress radiographs | Pre-operative | stress radiographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Scale (NPS) (0-10 rating) | Baseline and 6 months | Pain scale 0-100 |
| Measurements by physical therapists (Edema, thigh circumference) | 4,7, and 10 months after surgery | Measurements with tape |
| Measurements by physical therapists (range of motion) | 4,7, and 10 months after surgery | Measurements with goniometer |
| Measurements by physical therapists (Quadriceps strength, gait analysis) | 4,7, and 10 months after surgery | Measurements by biomechanics lab |
| Patient reported outcome scores | Baseline, 3 months, 6 months, 1 year | Surveys: International Knee Documentation Committee (IKDC), Cincinnati Knee Rating System (Cincinnati), Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm Knee Scoring Scale (Lysholm), and Veterans Rand 12 (VR-12) or Short Form-12 (SF-12) General Health Survey, lower extremity functional scale, Sports Medicine Questionnaire and survey/patient satisfaction |
Countries
United States
Contacts
Primary ContactBecky McGaver
Backup ContactKayla Seiffert
Outcome results
None listed